Development Activities NovaDel shall not be required to commence any Development Activities until Licensee has paid at least twenty-five percent (25%) of the non-refundable License Fee described in Section 4.4.
Protocol (cc) Part 2(b) of the ISDA Schedule – Payee Representation.
Independent Activities 14.1 Except as expressly provided herein, each party shall have the free and unrestricted right to independently engage in and receive the full benefit of any and all business endeavours of any sort whatsoever, whether or not competitive with the endeavours contemplated herein without consulting the other or inviting or allowing the other to participate therein. No party shall be under any fiduciary or other duty to the other which will prevent it from engaging in or enjoying the benefits of competing endeavours within the general scope of the endeavours contemplated herein. The legal doctrines of "corporate opportunity" sometimes applied to persons engaged in a joint venture or having fiduciary status shall not apply in the case of any party. In particular, without limiting the foregoing, no party shall have any obligation to any other party as to:
Regulatory Activities Beginning on the Effective Date and to the extent UGNX remains the Lead Development Party with respect to a particular territory, subject to and in accordance with the terms and conditions of this Agreement and the requirements of Applicable Laws, UGNX, shall: (a) use Commercially Reasonable Efforts to file (or have filed) all Regulatory Filings with respect to the Licensed Products in the Field in order to obtain Marketing Approvals in each country in the Territory and the European Territory (or to obtain the European Centralized Approval in the European Core Territory) and in order to obtain Pricing and/or Reimbursement Approvals in the Profit Share Territory; (b) respond in a timely fashion to requests for data and information from Regulatory Authorities with respect to the Licensed Products in the Field in the Territory and the European Territory; and (c) meet with officials of the Regulatory Authorities at such times as may be requested by such Regulatory Authorities with respect to the Core Development Activities (“Regulatory Activities”), provided that KHK will have primary responsibility for obtaining, and UGNX shall provide all assistance reasonably requested by KHK, in relation to Pricing and/or Reimbursement Approvals for the Licensed Products in the Field in the European Territory. For the avoidance of doubt, UGNX will be responsible for obtaining, and KHK will provide all assistance reasonably requested by UGNX, in relation to Pricing and/or Reimbursement Approvals, if any, for the Licensed Products in the Field in the Profit Share Territory as part of the UGNX Core Development Activities, it being understood that the costs incurred by UGNX in connection with such activities will be shared equally (50/50). All such Regulatory Activities will be conducted in a manner consistent with the Core Development Plan and coordinated by the JSC in accordance with Article 3. Without limiting the applicability of the foregoing and the remainder of this Article 5, UGNX shall interface with the applicable Regulatory Authority(ies) and, through the JDC, shall keep KHK reasonably informed of all material events and developments occurring in the course of the Regulatory Activities, including scheduled UGNX regulatory strategy discussions and meetings with Regulatory Authorities in the Territory and the European Territory relating to the Licensed Products in the Field.
Tests and Preclinical and Clinical Trials The preclinical studies and clinical trials conducted by or, to the Company’s knowledge, on behalf of the Company, that are described in the Registration Statement, the Pricing Disclosure Package and the Prospectus, as applicable, and are intended to be submitted to the U.S. Food and Drug Administration (the “FDA”) or other comparable government entities, were and, if still ongoing, are being conducted in all material respects in accordance with experimental protocols, procedures and controls pursuant to accepted professional scientific standards and all Authorizations and Applicable Laws, including, without limitation, current Good Clinical Practices and Good Laboratory Practices and any applicable rules and regulations of the jurisdiction in which such trials and studies are being conducted; the descriptions of the results of such studies and trials contained in the Registration Statement, the Pricing Disclosure Package and the Prospectus are, to the Company’s knowledge, accurate and complete in all material respects and fairly present the data derived from such studies and trials; except to the extent disclosed in the Registration Statement, the Pricing Disclosure Package and the Prospectus, the Company is not aware of any studies or trials, the results of which the Company believes reasonably call into question the study or trial results described or referred to in the Registration Statement, the Pricing Disclosure Package and the Prospectus when viewed in the context in which such results are described and the clinical stage of development; and, except to the extent disclosed in the Registration Statement, the Pricing Disclosure Package or the Prospectus, the Company has not received any written notices or written correspondence from the FDA or any governmental entity requiring the termination or suspension of any preclinical studies or clinical trials conducted by or on behalf of the Company, other than ordinary course communications with respect to modifications in connection with the design and implementation of such trials, copies of which communications have been made available to you.
Competitive Activities For purposes of the Agreement, to which this Exhibit B is attached, “Competitive Activities” means any activities relating to products or services of the same or similar type as the products or services (1) which were or are sold (or, pursuant to an existing business plan, will be sold) to paying customers of the Company or any Related Company, and (2) for which you have any direct or indirect responsibility or any involvement to plan, develop, manage, market, sell, oversee, support, implement or perform, or had any such responsibility or involvement within your most recent 24 months of employment with the Company or any Related Company. Notwithstanding the previous sentence, an activity shall not be treated as a Competitive Activity if the geographic marketing area of such same or similar products or services does not overlap with the geographic marketing area for the applicable products and services of the Company or any Related Company.
Development Plan As defined in Section 3.2(a).
Regulatory Compliance Program of the Sub-Adviser The Sub-Adviser hereby represents and warrants that:
Benchmarking 6.5.1. Not earlier than [***], Company shall have the right, but not the obligation, to conduct a measurement and comparison benchmarking process to compare [***] to ensure that Company is receiving [***], given the nature, volume and type of Services provided by Amdocs hereunder (taking into account the volume of Services, the skill sets and geographical location of the Personnel and other such factors necessary to ensure a like-for-like comparison to the benchmark comparator group) (the “Benchmarking Process”). Upon Amdocs’ receipt of notice of Company’s intent to exercise its benchmarking right, the Parties shall agree on a pool of suitably qualified, experienced and independent benchmarkers generally in the business of conducting such measurements and comparisons. The pool of benchmarkers shall not include any Person that is an Amdocs Competitor. It is the Parties’ intention that they shall jointly select the benchmarker to carry out the Benchmarking Process. However, in the event that the Parties are unable to agree as to the identification of such benchmarker, after escalation of this matter to Company’s Senior Vice President (IT) and Amdocs’ Vice President, then Company may utilize any Third Party benchmarker from the pool to perform the Benchmarking Process (the “Benchmarker”). The Benchmarker will review its benchmarking methodology with Company and Amdocs and the Parties shall agree to the criteria used for selection of the benchmark comparator group prior to commencement of the Benchmarking Process. Amdocs shall have reasonable * Confidential treatment has been requested. The redacted material has been separately filed with the Commission. opportunities to make submissions to the Benchmarker as to the performance of the Services and the related pricing. Company shall pay the fees and expenses charged by the Benchmarker (which fees will not be contingency-based). Amdocs’ cooperation with the Benchmarker shall be conditioned on the Benchmarker’s compliance with Amdocs’ commercially reasonable confidentiality requirements; provided, that, Amdocs shall not be obligated to disclose Confidential Information related to any of Amdocs’ or its Affiliates’ other clients to the Benchmarker. The Benchmarking Process shall be conducted so as not to unreasonably disrupt Amdocs’ operations under this Agreement (including so as not to lead to any material impact on the Service Levels).
